DEVICE: Calibration gas 1 (05700699621405)
Device Identifier (DI) Information
Calibration gas 1
962-140
In Commercial Distribution
962-140
Radiometer Medical ApS
962-140
In Commercial Distribution
962-140
Radiometer Medical ApS
Gas cylinder 2.5L Gas 1: 5.61 % CO2, 19.76 % O2
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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52859 | Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator |
A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep oil and grease away. Keep container in a well-ventilated place. Handle it with care and never subject it to shocks or blows. Always store and ship it with the valve closed. |
Storage Environment Temperature: between -25 and 60 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e379232f-5556-42c1-9fa1-95667aae0ba2
March 29, 2018
2
September 01, 2016
March 29, 2018
2
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+459999999999
radiometer@radiometer.dk
radiometer@radiometer.dk